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TOKYO (March 24, 2014) – Amgen Astellas Biopharma K.K. (Head Office: Chiyoda-ku, Tokyo, Japan. President: Eiichi Takahashi, hereafter Amgen Astellas) today announced that the Phase 2 YUKAWA (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). The mean percentage of LDL-C reduction, as measured by the accepted standard, preparative ultracentrifugation, was 69 percent with subcutaneous evolocumab 140 mg every two weeks and 64 percent with evolocumab 420 mg subcutaneous monthly, as compared to placebo. These positive data were reported on March 21, 2014, at the 78th Annual Scientific Meeting of the Japanese Circulation Society. The same study results were published electronically on March 21st in the online Circulation Journal of the Japanese Circulation Society.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood.1
The YUKAWA Phase 2 double-blind, randomized, placebo-controlled study evaluated the safety, tolerability and efficacy of evolocumab in 307 statin-treated Japanese patients at high risk for cardiovascular events. Patients were randomized to one of six treatment groups to compare subcutaneous evolocumab (70 mg and 140 mg every two weeks or 280 mg and 420 mg monthly) with subcutaneous placebo (every two weeks or monthly).
The occurrence of adverse events (AEs) was generally balanced across treatment groups. The three most common AEs were nasopharyngitis, increased creatine phosphokinase and arthralgia. There was no correlation of AEs with evolocumab dose levels or administration intervals.
The lead author, Professor Atsushi Hirayama of Nihon University Graduate School of Medicine, Department of Cardiovascular Medicine, said, “These study results showed that evolocumab, the PCSK9 inhibitor with a novel mechanism of action, improves lipid parameters at the same dose level as overseas studies in Japanese patients. We look forward to the results of the Phase 3 study in Japanese patients (YUKAWA-2) and the multinational collaborative study (FOURIER), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease, including Japanese patients.”
The overseas clinical data of evolocumab are scheduled to be presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), being held March 29 – 31 in Washington, D.C., USA.
Evolocumab (AMG 145) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood.2 Evolocumab, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.1
High cholesterol is the most common form of dyslipidemia, which is an abnormality of lipids in the blood.3,4 There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.5 According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C6, or “bad” cholesterol, and elevated LDL-C is recognized as a major risk factor for cardiovascular disease.7
Amgen Astellas BioPharma K.K. is a Japanese company that began operations on October 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen Inc., the world’s largest independent biotechnology company, and Astellas Pharma Inc., a leading Tokyo-based R&D-oriented global pharmaceutical company. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020. Amgen Astellas BioPharma leverages the capabilities of both companies – Amgen’s science and pipeline candidates coupled with Astellas’ deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading company in Japan – to contribute to the creation of a healthy society.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Astellas Pharma Inc. (http://www.astellas.com/jp/) is a pharmaceutical company headquartered in Tokyo, Japan, with total of 17,000 employees. From our business philosophy, we think our mission is “to contribute to the health of people around the world through the provision of highly effective and trustworthy pharmaceuticals.” We are proactive research and development oriented pharmaceutical company that has global reach, and specialize in five research areas: urology, immunology (including transplantation) and infectious diseases, oncology, and diabetes complications and nephrology. We aim to establish ourselves as the global leader in these therapeutic fields.
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Keiko Nakamura (Value, Access and Policy)
Amgen Astellas BioPharma K.K.
Chitose Yamada, Communications
inVentiv Medical Communications